On June 14: 2021 Philips issued a recall on millions of CPAP, BiPAP, and ventilators. Which the FDA has identified as a Class 1 recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Philips Respironics, Inc., is recalling its Continuous and Non-Continuous Ventilators due to the polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, which may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device. The exposure to debris or chemicals could cause serious adverse events in patients such as irritation (skin, eye, and respiratory tract), inflammation, headache, asthma, hypersensitivity, nausea/vomiting, adverse effects to other organs (e.g., kidneys and liver) and toxic carcinogenic effects.
There have been more than 1200 complaints and more than 100 injuries reported for this issue.
For patients using life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed therapy until you have talked to your physician.
Here is what Philips said in their recall and website below:
“Stop use of BiLevel PAP & CPAP sleep apnea devices Consult with your physician to determine the benefits of continuing therapy and potential risks.” List below
“Continue life-sustaining ventilation prescribed therapy Consult with your physician as soon as possible to determine appropriate next steps.“
